Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
NCT ID: NCT01203384
Last Updated: 2015-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2010-09-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CHF5074 1x
oral tablet, multidose
CHF5074 1x
oral tablet, 1x, once a day in the morning for 14 days
CHF5074 2x
oral tablet, multidose
CHF5074 2x
oral tablet, 2x, once a day in the morning for 14 days
CHF5074 3x
oral tablet, multidose
CHF5074 3x
oral tablet, 3x, once a day in the morning for 14 days
Placebo
placebo, oral tablet, multidose
Placebo
oral tablet, placebo, once a day in the morning for 14 days
Interventions
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CHF5074 1x
oral tablet, 1x, once a day in the morning for 14 days
CHF5074 2x
oral tablet, 2x, once a day in the morning for 14 days
CHF5074 3x
oral tablet, 3x, once a day in the morning for 14 days
Placebo
oral tablet, placebo, once a day in the morning for 14 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
* Significant allergic conditions that require medical treatment
* Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
* Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
18 Years
45 Years
MALE
Yes
Sponsors
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CERESPIR
INDUSTRY
Responsible Party
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Principal Investigators
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Magdy L Shenouda, MD
Role: PRINCIPAL_INVESTIGATOR
Iberica Clinical Research Center
Locations
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Iberica Clinical Research Center
Eatontown, New Jersey, United States
Countries
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Other Identifiers
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CCD-0913-PR-0038
Identifier Type: -
Identifier Source: org_study_id
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